Response to Addyi

Men have Pills for their Sexual Dysfunction, Why Can’t Women?

A Response to “How Addyi, the ‘Female Viagra,’ Can Do More Harm Than Good” By Dr. James A Simon

Earlier this month, Dr. Janet Brito, a sex therapist based in Hawaii, raising a few questions about the efficacy and wisdom in using Addyi, known as the “Female Viagra,” to treat sexual dysfunction in women. The article she wrote has been removed from that site that posted it due to the inaccuracy of the information the article contained. In spite of this, I felt that it was important to address her concerns, and to explain how Addyi is, in fact, an empowering tool that women who are suffering from hypoactive sexual desire (HSDD) or female sexual interest/arousal disorder (FSAD).

Efficacy and Use

Regarding the efficacy and use of Addyi, Dr. Brito makes several claims that are either blatantly false or not based in fact. She states that Addyi “needs to be taken every day for at least 8 to 16 weeks before it starts working.” According to the package insert itself (approved by the FDA), if Addyi isn’t working by 8 weeks, its use should be discontinued.

Brito brings up the fact that “according to the Addyi website, ‘it’s exact mechanism of action is not fully understood,’” without any other comment, perhaps implying that this is a reason it should not be used, but this fact is also true for all antidepressants, pain killers, appetite altering medications and most medicines generally.

“Initially, flibanserin was slated for the treatment of depression. After two rejections by the FDA, Addyi was approved in 2015 to treat low sexual desire in premenopausal women — despite trials showing only minimal results compared to a placebo,” states Dr. Brito. Addyi was originally developed to treat depression, but in people with major depressive disorder where Addyi didn’t work for depression, it increased sexual desire. That’s correct, it worked to increase sexual desire even in women that were clinically depressed.

Thus, the company behind Addyi pursued sexual dysfunction as an option to help women suffering from hypoactive sexual desire disorder or HSDD or female sexual arousal disorder or FSAD. The drug was rejected twice by the FDA, in my opinion, because the FDA kept changing their mind about what they wanted.

The company was trying to develop a first-in-class medication where the tools for assessing efficacy weren’t invented yet. For responders to the medication (excluding all the non-responders), they had 5.7 sexual events per month, which can’t be considered minimal, and which the responders themselves judged as a meaningful improvement.

“Their desire stats did change and show an increase when researchers measured it according to the Female Sexual Function Index — but if participants didn’t notice their own response, can it really be considered effective?” asks Dr. Brito. The Female Sexual Function Index is a validated questionare answered by the study participants, an approach agreed upon with the FDA. Participants reply to the FSFI based on how they, the participants, feel.

Social Oppression and Relationships

Dr. Brito spends a great deal of the article drawing a connection between a pill to treat sexual dysfunction for women and a long history of societal oppression of women. I fail to see the connection, as Addyi is only prescribed to patients who wanted to increase their sexual desire for one reason or another, not because their partners or society had problems with their libidos as Brito suggests.

Brito’s other accusation that those who prescribe Addyi are not taking into account any of the other factors that might contribute to low sexual desire, is not based in fact. Study participants were excluded from entering the research studies if they had any other reason for their loss of sexual desire, any reason. Such reasons would have included: depression or other medical conditions, medications known to affect sexual function, and any relationship problems, just for examples. Erectile Dysfunction has many causes and factors, and yet men are prescribed Viagra without a second thought. Shouldn’t women have equal access to a pill that can help them with their sexual function, too?

Like those who are prescribed a pill for depression, Addyi can help women start living their lives again, and get back to their old selves.

Brito also writes, “…sometimes the issue is about the relationship you have with yourself, not others.” On this point, I totally agree. But women with relationship problems with themselves or their partners were excluded from the clinical development of Addyi as noted above. Addyi is there for women who have been diagnosed with HSDD or FSAD, who are in a healthy relationship with their partners, and who want to get back to enjoying their partners sexually.

Dr. Brito concludes the article with this line, “Instead, ask yourself, honestly, if any of the aforementioned factors are impacting your life. And, if so, what lifestyle changes to embark on to start to feel better on your terms.” Addyi, Viagra, anti-depressants, and a slew of other medications may not be the best choice for every patient, but the patient does have a choice.

Why a sex therapist (who cannot even prescribe Addyi or medication generally) is ruling out a drug that is effective, readily available, and which delivers on the promise to increase “sexual desire and satisfying sexual events,” is beyond me.

To discuss if Addyi might help you or determine if you might be suffering from HSDD or FSAD, give us a call at 202.293.1000 or e-mail us to make an appointment at our office in Washington, D.C.

Contributed by

James A. Simon

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